AcceleRET-Lung Version 1
Research type
Research Study
Full title
A Randomized, Open-Label, Phase 3 Study of Pralsetinib versus Standard of Care for First Line Treatment of RET fusion-positive, Metastatic Non-Small Cell Lung Cancer
IRAS ID
274833
Contact name
James Spicer
Contact email
Sponsor organisation
Blueprint Medicines Corporation
Eudract number
2019-002463-10
Duration of Study in the UK
3 years, 4 months, 6 days
Research summary
Lung cancer causes the largest number of deaths from cancer worldwide. Despite the available treatments, survival for advanced lung cancer remains poor and new therapies are required. Recently a number of genetic alterations that drive development of lung cancer have been identified. Therapies that target these alterations show significant improvement in survival compared to standard treatment. RET fusion is one of such alterations for which there is no approved therapy. Pralsetinib is a new drug that is being developed for treatment of RET fusion-positive non-small cell lung cancer (NSCLC). NSCLC comprises 85% of lung cancer cases. RET fusion is found in 1-2% of NSCLC cases.
This study will compare the effects of pralsetinib on survival against standard treatments in patients with previously untreated advanced RET fusion-positive NSCLC . About 250 patients will be randomised 1:1 to receive either pralsetinib or one of 6 standard treatments that is best suited to treat their cancer. Patients will take pralsetinib capsules by mouth daily. Standard treatment will be given by infusion into a vein in 21-day cycles. Patients receiving standard treatment who experience disease progression may also be offered pralsetinib.
To be able to participate patients will need to have RET fusion alteration in their tumour confirmed by central testing of archival or fresh biopsy sample.
Study assessments include evaluation of medical history and use of other medications, recording of side effects, questionnaires, physical examinations, vital signs, blood and urine tests, pregnancy tests in females, tumour biopsies, CT and/or MRI scans.
The study will run for about 4 years at multiple sites in the North America, Europe and Asia-Pacific regions with up to 7 sites in the UK.REC name
London - Westminster Research Ethics Committee
REC reference
20/LO/0223
Date of REC Opinion
7 May 2020
REC opinion
Further Information Favourable Opinion